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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 10904
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2017
Event Type  Injury  
Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).

 
Event Description

A customer reported that continuously having a problem with fibers being seen during cataract procedure. These fibers appear to be the same color as the mayo stand or back table cover material. A small long blue fiber (presumably from the drape) was seen in the anterior chamber. Removed on post op day-was seen in wound. A cannula was used to attempt to aspirate the fiber. The fiber was no longer visualized.

 
Manufacturer Narrative

There have been no additional complaints reported against the finished goods lot and the device history record shows the product was released per specifications. The customer reported that they have had multiple problems with fibers being found during surgery. The fibers appear to be the same color as the mayo cover and back table cover. A sample was not returned for this complaint. When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted. The root cause of the customer's complaint is not known; as a sample was not returned to conduct a proper investigation. Action will not be taken for this occurrence. Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary. It is also recommended that the customer place the instruments on a mayo tray and avoid placing them directly on the mayo stand cover or back table cover. Additionally, the instruments should be wiped before passing back to the surgeon. This will assist in preventing lint contamination on instruments. (b)(4).

 
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Brand NameCUSTOM-PAK SURGICAL PROCEDURE PACK
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LTD. - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
nadia bailey
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8176152230
MDR Report Key7116867
MDR Text Key94821182
Report Number1644019-2017-00838
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device Catalogue Number10904
Device LOT Number1997503H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/18/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/14/2017 Patient Sequence Number: 1
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